Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F)
Caries-preventing Effect of 2% Calcium Hypophosphite Toothpaste Compared to a Sodium Fluoride Toothpaste (1450ppm F) in Adults
1 other identifier
interventional
164
1 country
2
Brief Summary
The aim of the study is to compare the caries-preventive effect of the test and control toothpaste in order to proof the non-inferiority of the test toothpaste compared to the control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2025
CompletedFirst Posted
Study publicly available on registry
July 16, 2025
CompletedStudy Start
First participant enrolled
January 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
April 13, 2026
April 1, 2026
1.9 years
July 7, 2025
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) regarding the Decay-Missing-Filled index
Comparison between the 2% Calcium Hypophosphite Toothpaste and Sodium Fluoride Toothpaste (1450 ppm F): Proportion of subjects showing no increase in overall Decay-Missing-Filled index during the observation period of 546 days (assessed by the investigator).
Day 1, Day 182±28, Day 365±28 vs. Day 546±28
Secondary Outcomes (2)
Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of interproximal caries lesions
Day 1 vs. Day 546±28
Evaluate the efficacy of 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of dental plaque deposition using the Plaque Control Record (PCR) index
Day 1, Day 182±28, Day 365±28 vs. Day 546±28
Study Arms (2)
2% Calcium Hypophosphite Toothpaste
EXPERIMENTALSodium Fluoride Toothpaste (1450 ppm F)
PLACEBO COMPARATORInterventions
Oral hygiene instruction and regular application of the 2% Calcium Hypophosphite Toothpaste at home (twice daily over a period of 546 days, i.e., 18 months).
Oral hygiene instruction and regular application of the Sodium Fluoride Toothpaste at home (twice daily over a period of 546 days, i.e., 18 months).
Eligibility Criteria
You may qualify if:
- A minimum of 10 healthy molars and premolars (DMFS of these teeth = 0)
- Willingness to use an electric (powered) toothbrush
- Willingness to use interdental floss
- Willingness to have bitewing radiographs taken
- Willingness to undergo an oral examination by an intraoral camera (DIAGNOcam)
You may not qualify if:
- Untreated caries \[clinical investigation and analysis with an intraoral camera (DIAGNOcam)\] (→ unsuitable subjects with one or two untreated caries in need of a restoration can become eligible after restorative therapy. If there are three or more untreated caries patients will be excluded)
- Xerostomia (medication, radiation, disease induced)
- Chemo/radiation therapy
- Physical or mental disability which prevents proper oral health care
- Orthodontic treatment
- Severe periodontitis at the Baseline Visit (pocket depth on at least one tooth ≥ 5.5 mm)
- Known hypersensitivity to one of the ingredients of the toothpastes to be tested
- Regular medication intake interfering with salivary function or flow
- Current pregnancy, the wish to become pregnant, the suspicion of being pregnant, or breastfeeding or in the course of the study
- or more carious lesions/restorations in last 36 months until Baseline Visit
- Teeth missing due to caries in last 36 months until Baseline Visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Integrated Dentistry Medical University of Białystok
Bialystok, Poland, 15-276, Poland
Poznan University of Medical Sciences, Department of Integrated Dentistry
Poznan, Poland, 60-812, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elzbieta Paszynska, Prof., DDS, Msc, PhD
Poznan University of Medical Sciences
- PRINCIPAL INVESTIGATOR
Malgorzata Pawinska, Assoc. Prof., DDS, PhD
Department of Integrated Dentistry Medical University of Białystok
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior Scientist Oral Care
Study Record Dates
First Submitted
July 7, 2025
First Posted
July 16, 2025
Study Start
January 22, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share